By way of comment I will simply paste an excerpt from an article I just wrote for the next issue of NeuroPractice (a Lippincott-Raven monthly which goes out to neurologists in the US/Canada, and with which I have absolutely no business relationship other than as a member of their Editorial Board), an article which overviewed the next generation of stroke drugs:
"Citicoline has three putative modes of action: 1) It repairs neuron membranes 2) it has a neuroprotective effect via the reduction of free fatty acids and radical oxygen species; 3) it boosts acetylcholine levels a compensatory/augmentation effect. Since it has at least a 24 hour `window' of usability post-infarct, approximately 85% of stroke patients are eligible for its utilization. No significant side effects are noted, there was an incidence of nausea in some indicated by the preliminary data, but none of the safety concerns so worrisome with t-PA. Given 500mg orally qd, for six weeks post-infarct, it is also an easy regimen to follow. Since citicoline and t-PA have such different mechanisms of action, when patients are seen quickly after an infarct, both will likely be used in concert, and there is animal data suggesting that the two drugs together are at least additive in their effect.
The FDA is going to be very receptive to citicoline since its risk/benefit profile is so strikingly positive. An Advisory Committee panel may be required because citicoline is a `new chemical entity', and to provide a counterpoint to the lubeluzole NDA. Even if an AC is required, citicoline should be approved by summer 1998, and launched by Interneuron under the tradename CerAxon soon thereafter. If the FDA moves expeditiously and does not require an AC, the timetable could accelerate by several months. Most observers anticipate that citicoline will find rapid acceptance (sales in Europe and Japan currently are approximately $230 million per year). Indeed, by 1999, we suspect that, from both a clinical and a liability-awareness perspective, that the burden of justification may shift to why one would not employ citicoline/CerAxon in a case of ischemic stroke."
I do agree that citicoline is far more important to IPIC than is Redux, indeed Redux may be contributing revenue (decreasingly) to IPIC, but I think its negative PR is cutting $4-6 off the share price at present. NeuroInvestment |
